Quality Assurance Specialist (Senior)

Competitive
Permanent
Dublin
09 Jan 2020
BBBH750431

Quality Assurance Specialist (Senior) Required-Pharmaceutical MNC -Dublin

Quality Assurance Specialist (Senior)

This position sits within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Key Responsibilities

Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.

Quality review and approval of Validation documentation and SOPs to support site validation activities:

o Review of DS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports

Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations.

  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
  • Perform all activities in compliance with Amgen safety standards and SOPs

Qualifications

  • Degree in Science, Engineering or related discipline
  • 5yrs + experience within the pharmaceutical or biotechnology industry
  • Understanding of principles of Validation and New Product Introduction
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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